Documentation Controller

AbbvieSligoFull-timeTemporary

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.


Unleashing your full potential? We OFFER that.

Rewarding career with ongoing development? We OFFER that too.

Welcome to AbbVie!

At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives worldwide. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond.

At our Manorhamilton Rd. site in Sligo, we have a high-potent commercialization and launch facility for small molecule API and Oral Solid Dose products. It is a young and vibrant site that is a strategic product launch facility within the wider AbbVie Operations network.

We are now recruiting for an experienced Documentation Controller on a 1-year Fixed Term Contract. In your new role as Documentation Controller, you will provide an effective document control system while carrying out the effective review of completed batch records.

So, are you ready to take the next step in your career and join the AbbVie team? Then read on to find out more…

In your new role, you will:

  • Control, distribution and archiving of documentation for the facility.
  • Ensure receipt of documents from the Global Documentation Management System.
  • Update, generation, maintenance and issuing of internal documentation.
  • Control of changes to documented procedures.
  • Completion of documentation audits and ensuring that the plant has the most up-to-date revisions of all documents.
  • Issue of Batch Record documentation.
  • Review/Audit of completed Batch Records.
  • Control of storage of completed batch records, validation documentation, engineering/ process validation documentation, and change requests.
  • Adhere to and support all EHS & E standards, procedures and policies.
  • Provide Management and Support for Doc Centre Helpdesk.
  • Support all PAI readiness activities.
  • Compilation and reporting of function Metrics and KPI’s.
  • Be responsible for ensuring that proper documentation controls and practices are adhered to and that effective batch records are completed for each work order.
  • Adhere to and follow all procedures, policies and guidelines to ensure compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.

Qualifications


Education:

  • A relevant qualification in an administrative discipline

Technical Skills:

  • Experience in a similar role working within the Pharma or related industry.
  • Strong IT skills essential.
  • Capable of collating and controlling technical documentation developed on site.
  • Strong interpersonal and decision making
  • High level of attention to detail and mental concentration, to ensure accuracy and total compliance with Quality procedures at all times.

So, does this all sound like the right role for you? Then join Abbvie!

AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.



Travel
No
Job Type
Temporary Work
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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